6.2.1 Modifications of existing law

A number of modifications of or adaptations to existing laws and mechanisms could be made, in order to create a more effective framework for the protection of traditional medicine. These include:

formalize customary law

Customary laws and practices are not uniform, but vary widely among different cultures and communities, yet, while generalizations would not do justice to the many intricate and diverse forms customary laws can take, most -if not all- share the same limitation: enforcement is limited to members of the community concerned. According formal status or providing for a legal basis to customary law systems would strengthen these systems and enhance their impact; this option should therefore be considered. For an example of how this could be done, see paragraph 8.5.

design 'tailor-made' contracts

Agreements and contracts can be concluded between interested stakeholders in order to address issues related to access, benefit sharing, prior informed consent and other rights and obligations. Such agreements can be negotiated on a case-by-case basis, according to the needs, wishes and possibilities of the parties concerned. Governments may enact legislation, mandating that formal agreements or contracts be signed -and specifying general principles and/or (minimum) conditions- before granting access to biological and genetic resources or knowledge. Costa Rica's experience (see paragraph 8.1) provides valuable insights in the crucial elements of such contracts and agreements.

modify patent and PVP law

Patent and plant variety protection (PVP) laws could be modified, in order to reduce the likelihood of biopiracy and of misuse or misappropriation of traditional knowledge, by requiring that applications for patents and plant variety protection include the following elements:

• certificate of origin, or statement disclosing the place(s) of origin of the material or knowledge used in the application;

• statement disclosing all communities or persons of origin;

• proof -or a declaration signed by the applicant- that informed consent has been obtained from the communities or persons from whom relevant (traditional) knowledge and/or resources were acquired;

• proof of benefit sharing arrangements with communities or persons of origin in accordance with relevant national guidelines;

• statement disclosing any previous rejection of the same application in any country;

• prior public notice of the patent/PVP application in all relevant languages in the places and communities of origin (in order to create opportunities for individuals or communities to oppose before protection is granted).

Box 11 Informed consent

The concept of informed consent is well-known; it is incorporated in several international agreements, such as the CBD, which requires "approval and involvement" of the knowledge holders as well as prior informed consent for access to genetic resources23, but also for example in the Basel Convention24 on international transport of toxic substances, which requires informed consent from a country to which toxic waste is exported.

In national laws however, generally, the principle of informed consent is lacking.

23 CBD, Article 8(j) and Article 15.5 respectively.

24 The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal.

Box 12 Declaration of origin and recognition of rights

In the Indian Patent Bill 1999 (2nd amendment) it has been made incumbent on the patent applicant to disclose the origin of biological materials used in the invention. Moreover, the grounds for rejection and revocation of a patent include non-disclosure, or wrongful disclosure, of the source of origin of biological resources and/or associated knowledge.

The Andean Group has established that any rights, including IPR, to genetic resources or derived products shall not be considered valid, if they have been obtained from any Member Country through non-compliance with the terms of access specified in the Andean Community Common System on Access to Genetic Resources. At the same time, national IPR offices in Andean countries are empowered to require applicants to submit a copy of their access contract as a pre-condition for obtaining intellectual property rights.

Patent and PVP laws could also be adapted, in order to make it easier for traditional knowledge holders to protect their knowledge and innovations, e.g. by:

• Providing for a special grace period for patent applications by holders of traditional knowledge, of 5 years. In some countries25, there is a grace period (usually 6 or 12 months) for filling a patent; once an inventor has disclosed his/her invention, he/she can still file for a patent until the end of this grace period. Since many holders of traditional knowledge share their knowledge and innovations in good faith with others, who may then publish and thus disclose them, a special, extended grace period for traditional knowledge holders would at least give them more time to 'catch up' and obtain protection.

25 E.g. Argentina, Mexico and the US.

• Providing for the eligibility of a 'wild discovered plant' for plant variety protection. This would mean that it is not necessary to make improvements in a plant for it to be considered a variety; even a wild plant, which is distinct, uniform and stable, could be protected as a variety by the person(s) who discovered it. This concept has been incorporated in China's Plant Variety Act (see also the slightly different example of Thailand, paragraph 8.2).

• Allowing the IPR office, in exceptional circumstances, e.g. when indigenous or local community members or representatives apply for protection of traditional (medicinal) knowledge and are unable to pay the required fees, to waive those fees. Kenya has recently incorporated a provision authorizing such waivers "where a natural person is unable to pay the prescribed fees" in the regulations under its IPR law.

modify other IPR forms

While other forms of IPR are only of limited relevance for the protection of traditional medicine (see chapter 4), certain modifications could enhance their usefulness somewhat. An example would be the explicit expansion of protection for geographical Indications to traditional medicines, and the setting up of a national, but also regional and international, system for registration of such geographical indications.